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Related Experiment Video

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Visualizing Field Data Collection Procedures of Exposure and Biomarker Assessments for the Household Air Pollution Intervention Network Trial in India

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Real world evidence: An Indian perspective.

Amit Dang¹, B N Vallish²

¹MarksMan Healthcare Solutions LLP, Kopar Khairane, Navi Mumbai, Maharashtra, India.

Perspectives in Clinical Research

|November 16, 2016

Summary

Real-world evidence (RWE) complements traditional randomized controlled trials (RCTs) by using real-world data (RWD) to assess drug safety and efficacy. India is developing a framework to harmonize RWD for better healthcare decisions.

Keywords:

Clinical outcome health economics health technology assessment humanistic outcome real world data real world evidence

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Area of Science:

Health Economics and Outcomes Research
Clinical Trial Design
Pharmacovigilance

Background:

Randomized controlled trials (RCTs) are the benchmark for drug evaluation but face increasing scrutiny from payers and providers seeking real-world evidence (RWE).
Real-world data (RWD) from diverse sources like electronic health records and registries are crucial for validating drug effectiveness and safety in routine clinical practice.
The global shift towards RWE necessitates its adoption in healthcare markets for robust decision-making.

Approach:

This work explores the growing importance of RWE in healthcare, contrasting it with traditional RCT methodologies.
It highlights the various sources of RWD that can be leveraged to generate meaningful insights.
The adoption of RWE approaches in developed nations is discussed as a precedent for other healthcare systems.

Key Points:

RWE provides valuable insights into drug performance and patient outcomes beyond controlled trial settings.
Diverse RWD sources, including administrative data and electronic health records, are essential for comprehensive RWE generation.
RWE is increasingly integral to market access and clinical practice validation for new medical interventions.

Conclusions:

The Indian healthcare sector is adopting health economics and outcomes research principles, recognizing the value of RWE.
India is establishing a framework to harmonize RWD, aiming to improve economic, clinical, and humanistic outcomes.
The integration of RWE is pivotal for informed healthcare decision-making and demonstrating the value of medical products in India.